BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 3102516 · Received May 9, 2013

    Report

    Report Number
    3015876-2013-00374
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER HAS ADVISED PHYSIO-CONTROL THAT THEY ARE LIKELY NOT GOING TO PURSUE REPAIRING THE DEVICE DUE TO THE COSTS ASSOCIATED AND THE AGE OF THE DEVICE. THE CUSTOMER HAS NOT RETURNED THE DEVICE TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE INDICATOR AND LOGGED A CRITICAL EVENT CODE WHICH WOULD EFFECT DEFIBRILLATION ENERGY DELIVERY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202946 LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1